TY - JOUR
T1 - A randomized controlled trial of teprenone in terms of preventing worsening of COVID-19 infection
AU - Ichihara, Eiki
AU - Hasegawa, Kou
AU - Kudo, Kenichiro
AU - Tanimoto, Yasushi
AU - Nouso, Kazuhiro
AU - Oda, Naohiro
AU - Mitsumune, Sho
AU - Yamada, Haruto
AU - Takata, Ichiro
AU - Hagiya, Hideharu
AU - Mitsuhashi, Toshiharu
AU - Taniguchi, Akihiko
AU - Toyooka, Shinichi
AU - Tsukahara, Kohei
AU - Aokage, Toshiyuki
AU - Tsukahara, Hirokazu
AU - Kiura, Katsuyuki
AU - Maeda, Yoshinobu
N1 - Publisher Copyright:
Copyright: © 2023 Ichihara et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
PY - 2023/10
Y1 - 2023/10
N2 - Background Some COVID-19 patients develop life-threatening disease accompanied by severe pneumonitis. Teprenone induces expression of heat-shock proteins (HSPs) that protect against interstitial pneumonia in preclinical models. We explored whether teprenone prevented worsening of COVID-19 infections. Methods This open-label, randomized, pilot phase 2 clinical trial was conducted at five institutions in Japan. We randomized patients hospitalized for COVID-19 with fever to teprenone or no-teprenone groups in a 1:1 ratio. We stratified patients by sex, age < and ≥ 70 years and the existence (or not) of complications (hypertension, diabetes, ischemic heart disease, chronic pulmonary disease and active cancer). No limitation was imposed on other COVID-19 treatments. The primary endpoint was the intubation rate. Results One hundred patients were included, 51 in the teprenone and 49 in the no- teprenone groups. The intubation rate did not differ significantly between the two groups: 9.8% (5/51) vs. 2.0% (1/49) (sub-hazard ratio [SHR] 4.99, 95% confidence interval [CI]: 0.59–42.1; p = 0.140). The rates of intra-hospital mortality and intensive care unit (ICU) admission did not differ significantly between the two groups: intra-hospital mortality 3.9% (2/51) vs. 4.1% (2/ 49) (hazard ratio [HR] 0.78, 95%CI: 0.11–5.62; p = 0.809); ICU admission 11.8% (6/51) vs. 6.1% (3/49) (SHR 1.99, 95%CI: 0.51–7.80; p = 0.325). Conclusion Teprenone afforded no clinical benefit.
AB - Background Some COVID-19 patients develop life-threatening disease accompanied by severe pneumonitis. Teprenone induces expression of heat-shock proteins (HSPs) that protect against interstitial pneumonia in preclinical models. We explored whether teprenone prevented worsening of COVID-19 infections. Methods This open-label, randomized, pilot phase 2 clinical trial was conducted at five institutions in Japan. We randomized patients hospitalized for COVID-19 with fever to teprenone or no-teprenone groups in a 1:1 ratio. We stratified patients by sex, age < and ≥ 70 years and the existence (or not) of complications (hypertension, diabetes, ischemic heart disease, chronic pulmonary disease and active cancer). No limitation was imposed on other COVID-19 treatments. The primary endpoint was the intubation rate. Results One hundred patients were included, 51 in the teprenone and 49 in the no- teprenone groups. The intubation rate did not differ significantly between the two groups: 9.8% (5/51) vs. 2.0% (1/49) (sub-hazard ratio [SHR] 4.99, 95% confidence interval [CI]: 0.59–42.1; p = 0.140). The rates of intra-hospital mortality and intensive care unit (ICU) admission did not differ significantly between the two groups: intra-hospital mortality 3.9% (2/51) vs. 4.1% (2/ 49) (hazard ratio [HR] 0.78, 95%CI: 0.11–5.62; p = 0.809); ICU admission 11.8% (6/51) vs. 6.1% (3/49) (SHR 1.99, 95%CI: 0.51–7.80; p = 0.325). Conclusion Teprenone afforded no clinical benefit.
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U2 - 10.1371/journal.pone.0287501
DO - 10.1371/journal.pone.0287501
M3 - Article
C2 - 37883347
AN - SCOPUS:85175271712
SN - 1932-6203
VL - 18
JO - PloS one
JF - PloS one
IS - 10 OCTOBER
M1 - e0287501
ER -